A Study on the Safety and Effectiveness of Rilpivirine Hydrochloride (Edurant) Among Adult Filipino Patients With Human Immunodeficiency Virus Type-I Infection

Withdrawn

• Conditions: Human Immunodeficiency Virus Type 1 (HIV-1) Infection
• Interventions: Drug: No intervention

• Registration Number: NCT01692470
• Lead Sponsor: Janssen Pharmaceutica

Brief Summary

The purpose of this study is to assess the safety and effectiveness of rilpivirine hydrochloride in combination with other anti-retroviral (ARV) medications for the treatment of ARV-naive (patients who have not been exposed to ARV) Filipino patients with human immunodeficiency virus type 1 (HIV-1) infection.

Detailed Description

This is an open-label (all people know the identity of the study medication), multi-center, observational (study in which the investigators/ physicians observe the patients and measure their outcomes) study. The total duration of the study will be 3 years, and approximately 60 patients who would use rilpivirine hydrochloride in routine clinical practice with a dosing regimen stipulated in the product insert (ie, 25 mg once a day) will be enrolled. As this is an observational study, assessment of patients will be based on the accepted clinical practice in the Philippines. Patients will be monitored from baseline and throughout the 48-week (2nd, 4th, 8th, 12th, 24th, 36th and 48th weeks) treatment period of rilpivirine hydrochloride.

Study Timeline

• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-25
• Study Start: 2013-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Filipino patients
• ARV naive patients with HIV-1 infection who are assessed by the physician to be eligible for treatment with ARVs
• Patients who voluntarily signed the informed consent form

Exclusion Criteria

• Patients receiving drugs known to prolong QTc intervals, medicinal products with a known risk of Torsade de Pointes and anticonvulsants, systemic dexamethasone, proton pump inhibitors
• Any previous treatment for HIV
• Previously documented HIV-2 infection
• Patients with viral load of >100,000 HIV-1 ribo nucleic acid (RNA) copies/ml
• Severely ill patients like those with acute acquired immune deficiency syndrome (AIDS)-defining illness or other major concomitant - disease prior to enrolment
• Patients with severe hepatic impairment
• Known hypersensitivity to rilpivirine hydrochloride
• Pregnant or breastfeeding females

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
rilpivirine hydrochloride	No intervention	Patients will be taking 1 tablet of 25 mg rilpivirine hydrochloride is administered once daily orally in combination with other anti-retroviral (ARV) medications.

Primary Outcome Measures

Name	Time	Method
Number of patients with incidence of adverse events	From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years
Number of patients with incidence of discontinuation of study medication due to adverse events	From the date of first exposure of study medication until 30 days after the last exposure of the patient to the study medication, as assessed for 3 years

Secondary Outcome Measures

Name	Time	Method
Number of patients who will not experience death due to acquired immune deficiency syndrome (AIDS) related events occurring after 6 months of treatment	Week 24, 36 and 48
Number of patients who will not develop virologic failure	Baseline (Week 1), Week 8, Week 24 and Week 48	Virologic failure defined as a persistently detectable viral load in a patient with previously suppressed human immunodeficiency virus ribo nucleic acid (HIV RNA) or the inability to achieve an undetectable viral load after 24 weeks of therapy. The level of undetectable load is less than 50 HIV-1 RNA copies/ml.
Number of patients who will not develop immunologic failure	Baseline (Week 1), Week 24 and Week 48	Immunologic failure defined as either of the following conditions: a) CD4 count below 100 cells/mm3 after 6 months of therapy; b) return to or a fall below, the pre-therapy CD4 baseline after 6 months of therapy; c) a 50% decline from the on-treatment peak CD4 value (if known)
Number of patients who will not have emergence of new (ie, not present at baseline) AIDS defining conditions while on treatment	Baseline (Week 1), Week 2, 4, 8, 12, 24, 36 and 48	AIDS defining conditions may include: HIV wasting syndrome, pneumocystis jiroveci, recurrent severe bacterial pneumonia, chronic herpes simplex infection, esophageal candidiasis, extrapulmonary tuberculosis etc.